6 during the treatment such as gastrointestinal bleeding, liver,
renal function impairment, visual impairment, blood abnormalities
and allergic reactions, which should be discontinued.

[Pregnant and Lactating women]

This product can be passed through the placenta. Animal test was
toxic to fetal rats, but not teratogenic. The use of this product
in pregnant women can prolong the pregnancy, cause dystocia and
prolonged labor. Therefore, pregnant women and lactating women
disabled.

[Medication for children]

Not suitable for children under 16 years of age.

[Medication in the elderly]

Elderly patients with caution.

Package Leaflet: Information for the PatientDiclofenac Sodium 75mg / 3ml Solution for InjectionRead all of this leaflet carefully before you are given this
medicine because it containsimportant information for you.- Keep this leaflet. You may need to read it again.- If you have any further questions, ask your doctor, nurse or
pharmacist.- This medicine has been prescribed for you only. Do not pass it on
to others. It may harmthem, even if their signs of illness are the same as yours.- If you get any side effects, talk to your doctor, nurse or
pharmacist. This includes anypossible side effects not listed in this leaflet. See section 4.The name of your medicine is Diclofenac Sodium 75mg / 3ml Solution
for Injection. It willbe referred to as Diclofenac Injection for ease hereafter.What is in this leaflet:1. What Diclofenac Injection is and what it is used for2. What you need to know before you are given Diclofenac Injection3. How you are given Diclofenac Injection4. Possible side effects5. How to store Diclofenac Injection6. Contents of the pack and other information1. What Diclofenac Injection is and what it is used forDiclofenac Injection contains the active substance Diclofenac
sodium which belongs to agroup of medicines called non-steroid anti-inflammatory drugs
(NSAIDs).Diclofenac Injection may be used when there is an increase in
severity of rheumatoid arthritisor osteoarthritis. It may also be used for acute back pain, acute
gout, pain after surgery orfollowing injury, fracture pain, or colicky pain from the kidney
area.2. What you need to know before you are given Diclofenac InjectionYou should not be given Diclofenac Injection• if you are allergic to Diclofenac Injection or any of the other
ingredients of DiclofenacInjection (listed in section 6)• if you have now, or have ever had, a stomach (gastric) or
duodenal (peptic) ulcer, orbleeding in the digestive tract (this can include blood in vomit,
bleeding when emptyingbowels, fresh blood in stools or black, tarry stools)• if you have had any allergic reaction to ibuprofen, aspirin, or
other NSAIDs (includingdifficulty in breathing, runny nose, swelling of the face or
throat, or rash)• if you have asthma• if you have kidney or liver problems.• if you are dehydrated or have recently lost a lot of blood• if you have severe heart failure• if you have a condition where you don’t stop bleeding normally
(such as haemophilia)• if you have had a stroke• if you are taking other non steroidal anti-inflammatory drugs• if you are taking anticoagulant drugs (medicines for preventing
blood clots, such as

heparin and warfarin)• if you are more than 6 months pregnant• if you are taking medicines known as SSRIs used to treat
depression.• if you have been told by your doctor that you have an intolerance
to some sugars• if you have had stomach or bowel problems after you have taken
other NSAIDs.• if you have established heart disease and /or cerebrovascular
disease e.g. if you have had aheart attack, stroke, mini-stroke (TIA) or blockages to blood
vessels to the heart or brain oran operation to clear or bypass blockages• if you have or have had problems with your blood circulation
(peripheral arterial disease)• if you are breast-feedingWarnings and precautionsTalk to your doctor, nurse or pharmacist before you are given
Diclofenac Injection:• If you smoke• If you have diabetes• If you have angina, blood clots, high blood pressure, raised
cholesterol or raisedtriglycerides.• If you have heart problems, previous stroke or think that you
might be at risk of theseconditions (for example if you have high blood pressure, diabetes
or high cholesterol or are asmoker) you should discuss your treatment with your doctor or
pharmacist.• If you suffer from any of the following: blood abnormalities,
bleeding conditions, Crohn’sdisease, inflammation of the colon.• If you have a history of any of the following: stomach or bowel
ulcers, vomiting of bloodor black, tarry faeces and Gastro-intestinal ulcers• If you have a history of stomach problems when you are taking
NSAIDs, particularly if youare elderly, you must tell your doctor straight away if you notice
any unusual symptoms.Because it is an anti-inflammatory medicine, Diclofenac may reduce
the symptoms ofinfection, for example, headache and high temperature. If you feel
unwell and need to see adoctor, remember to tell him or her that you are taking Diclofenac.• If you have heart, kidney or liver problems, or having medicines
to increase urine volumesuch as diuretics, your doctor may monitor your kidney function.• If you have kidney, liver or heart problems.• If you are pregnant.• If you have a history of high blood pressure and/or heart
failure.• If you suffer from or have previously suffered from asthma.• If you suffer from systemic lupus erythematous or mixed
connective tissue disorders.• If you are an older patient.• If you have had or are about to have major surgery.• If you suffer from any blood or bleeding disorder.ChildrenDiclofenac Injection is not recommended for use in children.Older peopleOlder people have increased frequency of adverse reactions to
NSAIDs especiallygastrointestinal bleeding and perforation which may be fatal.
Caution should be advised inpatients receiving concomitant medications which could increase the
risk of ulceration orbleeding, such as oral corticosteroids, anticoagulants such as
warfarin, selective serotoninreuptake inhibitors (SSRIs) or
anti-platelet agents such as aspirin.

Other medicines and Diclofenac InjectionTell your doctor, nurse or pharmacist if you are taking or have
recently taken any othermedicines. This includes any herbal products or medicines bought
without a prescription.• Digoxin (used to treat heart problems)• Lithium (used to treat mental illness)• Antibiotics called quinolones (such as ciprofloxacin)• Ciclosporin and tacrolimus (used to treat some inflammatory
diseases and after transplants)• Methotrexate (used for some inflammatory diseases and cancers)• Drugs that can increase your risk of bleeding, sometimes given if
you have heart problems,such as dipyridamole or clopidogrel• Diuretics (water tablets)• Medicines to treat high blood pressure• Mifepristone, used to terminate pregnancy (including if you have
taken it within the last 12days)• Medicines to treat diabetes• Oral steroids (an anti-inflammatory drug)• Steroids• Zidovudine (treatment of HIV infection)• Phenytoin (medicines to treat epilepsy)• Colestipol and cholestyramine (medicines to lower cholesterol
level)• CYP2C9 inhibitors: e.g. Sulfinpyrazone and voriconazole• Other NSAIDs (for painful or inflammatory conditions) including
COX2 inhibitors• Medicines known as SSRIs used to treat depression, such as
paroxetine or fluoxetine• Medicines used to treat heart conditions or high blood pressure
for example beta-blockers orACE inhibitors.Pregnancy, breast-feeding and fertilityIf you are pregnant or breast-feeding, think you may be pregnant or
are planning to have ababy, ask your doctor for advice before taking this medicine.PregnancyDiclofenac Injection should only be used during pregnancy when your
doctor decides thebenefits to you are greater than any possible risk to the unborn
baby.Do not take Diclofenac Injection during the last 3 months of
pregnancy as it may affect yourbaby’s circulation and kidneys.Breast-feedingDo not take Diclofenac Injection during breast-feeding as
Diclofenac passes into the breastmilk in small amounts.FertilityTaking Diclofenac Injection may make it more difficult to conceive.
You should talk to yourdoctor if you are planning to become pregnant, or if you have
problems getting pregnant.Driving and using machineryDiclofenac Injection may make you feel drowsy or dizzy, or cause
problems with vision. Ifyou are affected, do not drive or operate machinery.

Diclofenac Injection contains less that 1 mmol (23 mg) sodium per
3ml i.e. essentiallysodium free.Diclofenac Injection contains sodium metabisulphite which can cause
severe allergicreactions, especially in patients with a history of asthma or other
allergies.3. How you are given Diclofenac InjectionDiclofenac Injection can be given by deep injection into the large
muscle of the buttock. Theusual dose is one ampoule once daily. One ampoule twice daily may
be required in severecases, the second dose being injected into the buttock muscle on
the other side.The injection should not be given for more than 2 days. For colicky
pain from the kidney areathe dose is one ampoule injected into the buttock muscle and this
dose may be repeated after30 minutes if necessary.The total dose in one day should not exceed 150mg (two ampoules).Your doctor may decide on smaller doses if you are:• an older person• frail• or you have a low body weightIf you are given more Diclofenac Injection than you shouldIf you think you have been given too much Diclofenac Injection tell
your doctor or nursestraight away.If you have any further questions on the use of this medicine, ask
your doctor.4. Possible side effectsLike all medicines this medicine can cause side-effects although
not everybody gets them.Some side effects can be serious and you should tell your doctor
immediately if you noticethe following:• Mild cramping and tenderness of the abdomen, starting shortly
after the start of thetreatment with Diclofenac Injection and followed by rectal bleeding
or bloody diarrhoeausually within 24 hours of the onset of abdominal pain (frequency
not known, cannot beestimated from the available data)• Stomach pain, indigestion, heartburn, wind, nausea (feeling sick)
or vomiting (being sick)• Any sign of bleeding in the stomach or intestine, for example,
when emptying your bowels,blood in vomit or black, tarry faeces• Allergic reactions which can include skin rash, itching,
bruising, painful red areas, peelingor blistering• Wheezing or shortness of breath (bronchospasm)• Swollen, face, lips, hands or fingers• Yellowing of your skin or the whites of your eyes• Persistent sore throat or high temperature• An unexpected change in the amount of urine produced and/or its
appearance.• If you are bruising more easily than usual or have frequent sore
throats or infections

The following side effects have also been reported:Common (affects less than 1 in 10 people)·

Stomach painHeartburnNausea (feeling sick)Vomiting (being sick)DiarrhoeaIndigestionWindLoss of appetiteHeadacheDizzinessVertigoSkin rash or spotsRaised levels of liver enzymes in the blood.Injection site reactions, symptoms include redness,swelling, change in the skin colouror textureFluid retention, symptoms of which include swollen ankles

Rare (affects less than 1 in 1,000 people)

Asthma including shortness of breathDiarrhoea with blood in it or bleeding from the back passageBlood in vomit or black, tarry faecesLiver function disorders, including hepatitis and jaundiceStomach ulcers or bleeding (there have been very rare reported
cases resulting indeath, particularly in older patients)Gastritis (inflammation, irritation or swelling of the stomach
lining)Somnolence (sleepiness)Urticaria (raised, itchy rash)Shock (symptoms of which include weak and rapid pulse, confusion,
weakness or lowblood pressure)

Insomnia (sleeplessness)NightmaresIrritability (mood changes)AnxietyPsychotic disorder (mental disorders)Fits (convulsions)ConstipationHair lossBlistering of skinRecurring skin rashesSwelling of skin (including angioneurotic oedema with face oedema)ItchingInflammation of skin (Eczema)Red or purple discolorations on the skin (Exfoliative dermatitis)Severe upper abdominal painLower gut disorders (including inflammation of the colon)Narrowing of the bowel (which leads to intestinal obstruction)Worsening of ulcerative colitis (ulcers in the colon) or Crohn's
disease which ischaracterized by abdominal painMouth ulcersInflammation of the tongueInflammation of the inside of the mouth or lipsOesophageal disorder characterized by difficulty in swallowingHypertension (high blood pressure)Hypotension (low blood pressure)Aseptic meningitis (fever, nausea, vomiting, headache, stiff neck
and extremesensitivity to bright light)Inflammation of blood vessels (vasculitis)Kidney or liver disordersPresence of blood or protein in the urineDeath of kidney cell and inflammation of the kidneyAn unexpected change in the amount of urine produced and/or its
appearance whichmay be made worse by exposure to sunlightInflammation of the pancreasIncreased risk of heart attack or strokeChest painHeart disorders, including congestive heart failureBlood disorders (including anaemia).Palpitations (fast or irregular heart beat)Inflammation of the lung (pneumonitis)FeverBack pain

Not known: frequency cannot be estimated from the available data

Injection site necrosis (dead skin and tissue around the injection
site)ConfusionHallucinationsDisturbances of sensationImpotence

Optic neuritis (inflammation of the nerves in the eye)Malaise (General feelings of being unwell, weakness)

Reporting of side effectsIf you get any side effects, talk to your doctor or pharmacist.
This includes any possible sideeffects not listed in this leaflet. Side effects may be minimised
by using the lowest effectivedose for the shortest duration necessary.You can also report side effects directly via
www.mhra.gov.uk/yellowcard. By reporting sideeffects you can help provide more information on the safety of this
medicine.5. How to store Diclofenac Injection

Keep this medicine out of the sight and reach of children.Keep the container in the outer carton in order to protect from
light.Do not store above 25°C.Do not use after the expiry date shown on the carton. Once opened,
any unused liquidshould be discarded. The expiry date refers to the last day of that
month.· Do not throw away any medicines via wastewater or household
waste. Ask yourpharmacist how to throw away medicines you no longer use. These
measures will helpprotect the environment6. Contents of the pack and other informationWhat Diclofenac Injection containsThe active substance is Diclofenac sodium. Each ampoule contains
75mg of DiclofenacSodium in 3ml of solution. The solution is sterile and is
colourless or almost colourless.The other ingredients of the each ampoule are Sodium Metabisulphite
(E223), PropyleneGlycol, Benzyl Alcohol, Sodium Hydroxide and Water for Injections.What Diclofenac Injection looks like and contents of the packThe ampoules are available in 3ml strengths in clear glass ampoules
and are packed incardboard cartons containing 5 or 10 ampoules.

Established in 2014, WUHAN UNI-PHARMA BIO-TECH CO.,LTD is a
professional manufacturer and exporter that is concerned with the
design, development and production of pharmaceutical products
,Medical equipment, raw materials(API), veterinary drugs
pharmaceutical Intermediate ,single-use medical devices, surgical
dressing, dental material and instrument.

We are located in Wuhan city, Hubei province, with convenient
transportation access. All of our products comply with
international quality standards and are greatly appreciated in a
variety of different markets throughout the world.

We have over 10 employees, boast an annual sales figure that
exceeds USD10,000,000 and currently export 50% of our production
worldwide. Our well-equipped facilities and excellent quality
control throughout all stages of production enable us to guarantee
total customer satisfaction.

As a result of our high quality products and outstanding customer
service, we have gained a global sales network reaching Africa,
southeast Asia, Middle east Countries ,South America countries and
so on.

Committed to the mission of “Caring for Life and Attending to
Health”, we strive to implement the strategy of
internationalization and are engaged in services to the
international pharmaceutical industry. We have rich international
market experience and customer resources as well as excellent
management and assurance system of international business.

If you are interested in any of our products or would like to
discuss a custom order, please feel free to contact us. We are
looking forward to forming successful business relationships with
new clients around the world in the near future.